Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

Not Applicable

• Conditions: Surgery; Delirium; Delirium, Post-Operative
• Interventions: Other: Traditional Orientation Methods; Other: Virtual Reality Software

• Registration Number: NCT06232317
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

Detailed Description

Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.

A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.

Study Timeline

• Study Start: 2023-12-09
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ≥60 years of age
• Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
• Richmond Agitation-Sedation Scale (RASS) Score 0

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Exclusion Criteria

• Subjects with baseline cognitive impairment
• Person with active psychiatric disorders and being treated with medications, especially schizophrenia
• Person who is deaf or blind
• Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia)
• Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions
• Active seizure disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Orientation Methods	Traditional Orientation Methods	Participants in this arm will receive cognitive exercises using traditional (standard-of-care) orientation methods,
Virtual Reality Software	Virtual Reality Software	Participants in this arm will receive cognitive exercises using ReCognitionVR virtual reality software

Primary Outcome Measures

Name	Time	Method
Proportion of treatment-emergent adverse events (TEAE)	Within 1 month of enrolling in the study	Proportion of participants who experience a treatment-emergent adverse event

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Pulse Oximetry Oxygen Saturation after 10 Minutes	Baseline and 10 minutes	Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and 10 minutes after intervention. Change = 10-minute oxygen saturation - baseline oxygen saturation
Change from baseline in respiratory rate after 10 minutes	Baseline and 10 minutes	Respiratory rate at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and 10 minutes after intervention. Change = 10-minute respiratory rate - baseline respiratory rate
Change from baseline in systolic blood pressure after 10 minutes	Baseline and 10 minutes	Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and 10 minutes after intervention. Change = 10-minute systolic blood pressure - baseline systolic blood pressure
Change from baseline in diastolic blood pressure after 10 minutes	Baseline and 10 minutes	Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and 10 minutes after intervention. Change = 10-minute diastolic blood pressure - baseline diastolic blood pressure
Change from baseline in pulse oximetry oxygen saturation after completion	Baseline and completion of the intervention, up to 2 hours	Pulse oximetry oxygen saturation measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and after completion of intervention. Change = completion oxygen saturation - baseline oxygen saturation
Change from baseline in diastolic blood pressure after completion	Baseline and completion of the intervention, up to 2 hours	Diastolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and after completion of intervention. Change = completion diastolic blood pressure - baseline diastolic blood pressure
Change from baseline in respiratory rate after completion	Baseline and completion of the intervention, up to 2 hours	Respiratory rate at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and after completion of intervention. Change = completion respiratory rate - baseline respiratory rate
Change from baseline in systolic blood pressure after completion	Baseline and completion of the intervention, up to 2 hours	Systolic blood pressure measured using a vital sign monitor at baseline (immediately prior to intervention \[VR software or traditional orientation methods\]) and after completion of intervention. Change = completion systolic blood pressure - baseline systolic blood pressure
Positive Confusion Assessment Method and/or 4 A's Test	Baseline, 24 hours, 48 hours, 72 hours	The proportion of patients who have a positive Confusion Assessment Method (CAM) or 4 A's Test for delirium

Trial Locations

Locations (1)

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States